Recurrent Ovarian Cancer
Conditions
Keywords
neoantigen, dendritic cell vaccine
Brief summary
Effective treatments are desperately needed for ovarian cancer patients. This phase I clinical trial assesses the safety of a novel personalized dendritic-cell vaccine administered to ovarian cancer patients. Secondary outcomes will be evaluated such as patient pharmacodynamics， progression-free survival and overall survival.
Detailed description
This is a single arm, non-randomized phase I study to evaluate the safety and feasibility of delivering a novel dendritic cell vaccine in 6 to 12 (n=6-12) adult patients diagnosed with ovarian cancer after undergoing surgical resection. The vaccine contains both tumor-associated antigen and patient specific neoantigens. Standard-of-care chemotherapy therapy will be followed as per routine,during which patients enrolled into this study will receive a personalized vaccine in addition to standard of care. Effective adjuvant therapies are urgently needed for these patients given that high rate of recurrence still occurs after standard of care with poor prognosis among ovarian cancer patients. The study is constructed in a 3+3 algorithm for two steps of dose escalation with rigorous and mandatory safety monitoring.
Interventions
BIOLOGICALdendritic cell
Biological: Dendritic Cell Immunotherapy Adult patients with histopathologically diagnosed Ovarian Cancer will be eligible for this novel, personalized dendritic cell vaccine during course of standard of care chemotherapy. If unacceptable side effects are observed at a total dose of 5x106, as detailed in the study protocol, then a cohort of 3-6 enrolled patients will receive a de-escalated total dendritic cell dose of 2.5x106. If no unacceptable side effects are identified at a total dose of 5x106, as detailed in the study protocol, then a cohort of 3-6 enrolled patients will receive an escalated total dendritic cell dose of 1X107.
Sponsors
West China Second University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 18-75 years old female patients； 2. Histopathologically diagnosed recurrent stage III/IV epithelial ovarian cancer; 3. Normal liver, heart as well as kidney functions and blood chemistry; 4. Predicted survival for more than 6 months； 5. Provision of signed and dated informed consent form.
Exclusion criteria
1. Allergic to human albumin, an excipient of the manufactured dendric cell vaccine； 2. Predicted survival for less than 6 months； 3. Diagnosed with brain metastasis and other diseases unsuitable for cell therapy including but not limited to Myelodysplastic Syndromes、Acute Myeloid Leukemia and Systemic Lupus Erythematosus; 4. Diagnosed with viral diseases including but not limited to HIV, TP, HCV and HBV ； 5. Female patients who are pregnant, breast feeding, or of childbearing potential without a negative pregnancy test prior to baseline; 6. Other conditions deemed unsuitable for this study by the leading investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adverse events | up to 18 months | Patients will be monitored for adverse events as dictated by CTCAE version 5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics | up to 1 week | percentage of antigen-specific T cells in peripheral blood. |
| PFS | up to 18 months | Progression-free survival |
| OS | up to 18 months | Overall survival |
Countries
China
Outcome results
None listed